Clinical Research Organization: Challanges
Cost and Time are not the only concerns for Clinical Research. The spectrum is much broader in face of challenges encountered by the Clinical Trials. Delving deep one can easily depict the multifaceted challenges attached with the Clinical Researches.
Good Site Management – Selection of site and CRO’s for conducting and management of good site and trial is the base point of the Clinical Study. A failure at this step can influence the outcome of the study in both the directions. A good Site and CRO aspires for the success of Clinical Researches. Organizers must make sure that they opt for a first rate CRO to manage their operations and trials. CRO can reduce the time lines of Trial as they have effective pre-study planning and feasibility. They have experience of moving in that particular geographic location supporting good association (partnership) and rapport with experienced investigators and Regulatory Authorities. More to it, they possess good patients and volunteers database in their kitty. Further being professionals they have good command over all the areas of management of Clinical Trials.
Seeking a site with good infrastructure and apt facilities is a first step hurdle which should be encountered intelligently and broaden horizon of acquaintance with the aspects of location and clinical Researches.
Mere a jerk in their selection can be very disastrous for the Clinical research and can ruin whole of the study.
Public participation- Patient retention, the main component of Clinical Trial is something to be handled and managed very skillfully, stands as a great crux. Researchers identify it as a dilemma pool to cultivate active participation from people. The awareness and knowledge level regarding the Clinical Researches is so low that people never show their interest for the participation. Moreover they have certain rigid and set notion about Clinical Trials that they are not very eager for any drug research no matter it can result into their betterment.
Communication Channels & Awareness – The willing attitude from the society comes with effective communication through proper channels reaching the masses. When it comes to awareness among billions of people around the globe how many know what clinical research encompasses around or simply what Clinical Research and Clinical Trials meant? Leave out the layman even professionals in the field lacks to have knowledge about the previous discoveries and how those can be used for the future researches. A good literature study about the applied research is must requisite to be followed as a step for any research.
Technological Advancement- Every now and then ongoing modernization of Clinical Industry through Technologies tends to promise to accelerate the relative speed of trials. Today one can find numerous software modules for Clinical industry in the markets to enhance the rate of Clinical Trials. Few among them are LIMS (Lab Information Management System), EDC (Electronic Data Capture), IVRS (Interactive Voice Response System), ERP/MRP software, CTMS (Clinical Trial Management Systems), CDMS (Clinical Data Management Systems) etc. This exorbitant rise in technologies generally confuses people and they virtually find themselves entangled into the problematic technological web with no way out. If they go for multiple software, problem further arises with the improper interfacing of data and same data stored into all the software under different domains.
Workforce Training – After employing the professionally trained workforce, organizers simply shrug off all the responsibilities from their shoulders. Not realizing that any direction of study will not influence the workforce but will directly affect them only as their huge resources are invested into the study. Cultivating the sense of responsibility and inculcating the sense of association in workforce should be the prior duty of organizers to generate through proper training and discussions channels.
This is the one aspect of workforce training, other being the technological training. Organizers must keep their workforce aware of current trends in the research, Regulatory Affairs and the upcoming technologies that they are supposed to be used by them in the course of study.
Funding – Funding is a term that put every organizer of the study on their nerves. Clinical research incurs huge investment with no surety of success rate. A straight clinical research can cross $1 billion. The ambiguous success rate of study is something that dithers anyone to invest in the research. The funding issues should be tackled out with strategic and logical planning. The pros and cons should be measured and must be communicated through effective Channels.
Regulatory Issues – Variant structure of regulatory functionary in different countries create problems for the organizers to understand the meaning of the issues involved at different location and the solution that can be sought. Further within the boundaries also, inadequate knowledge about regulatory and ethical issues concerned is the big break-even point for the trials time lines. Better understandings among the workforce about ethical issues related with patients and drugs in the study is directly proportional to the growth rate of the Clinical Research.
